Events

Rappel de Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hardy Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74356
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2146-2016
  • Date de mise en oeuvre de l'événement
    2016-05-24
  • Date de publication de l'événement
    2016-07-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147263
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Slide stainer, automated - Product Code KPA
  • Cause
    Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
  • Action
    The firm began notifying consignees via phone on 05/23/16. The firm also sent out Urgent Notification letters, dated June 15, 2016. The firm's phone script instructs customers to decrease the number of rinses on the slide and increasing the number of rinses in the chamber for better outcomes and performance with the instrument. Reducing the rinses on the slide may prevent bacteria from coming off the slide, and adding rinses to the empty chamber will help ensure that the chamber is clean before the next slide is introduced. The firm's customer notification letter recommended an immediate update to the automated rinse cycle to decrease the number of slide rinses and increase the number of empty chamber rinses to improve instrument performance. A step-by-step procedure for updating the rinse cycle settings was discussed via phone and should now be implemented. In addition to the changes, the firm is updating the GramPro 80 User Manual to reflect new recommendations, and it is strongly recommended that all users perform methanol fixation of slides for automated staining and discontinue the use of heat fixation to prevent cross contamination of the unit. Once updates to the User Manual have been completed, the firm will provide an updated revision for customer records. For further information or technical assistance, contact QuickSlide Technical Team at gibbsd@HardyDiagnostics.com.

Device

Device Recall QuickSlide MGS80 MutliSlide Gram Stainer/GramPRO80
  • Modèle / numéro de série
    All units manufactured between October 2014 and May 2016.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Distribution to the following states: CA, TX, NE, OK, LA, NC, PA, AZ, NY, PA, VA, NM, MI, and WV.
  • Description du dispositif
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. || Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Adresse du fabricant
    Hardy Diagnostics, 1430 W McCoy Ln, Santa Maria CA 93455-1005
  • Société-mère du fabricant (2017)
    Hardy Diagnostics
  • Source
    USFDA